Patents

U of M Asserts Sovereign Immunity Prevents USPTO from Invalidating Its Patents

Prof. Richard Stern, MJLST Guest Blogger

The University of Minnesota owns a number of patents on cell phone signal processing technology that was invented by Professor Georgios Giannakis of U of M’s Department of Electrical and Computer Engineering and his colleagues. The U of M claims that AT&T, Sprint, T-Mobile, and Cellco Partnership (a joint venture between Verizon and Vodaphone, doing business as Verizon Wireless) are infringing five of these patents, and in 2014 it sued the companies in Minnesota federal district court for patent infringement. The U of M is “a great research university,” President Eric Kaler said, and “must vigorously protect our faculty, [their] discoveries and the overall interests of our university.” (The U collects about $40 million annually in royalties from licensing and the commercialization of faculty work.) Apparently, the cell phone carriers infringed the patents by utilizing Ericsson radio chips that code signals for wireless transmission and practicing patented methods the chips performed.

 

The case was assigned to Chief Judge John R. Tunheim in Minneapolis, who denied the defendants’ motion to dismiss the case for defective pleading, in September 2015. He did reject the U’s claim, however, that the defendants engaged in “willful blindness” in infringing the patents. Judge Tunheim said that the U “alleges no actions that would constitute deliberate avoidance of knowledge” that they were infringing, although they did know of the patents and they “actively entice[d] their customers through advertising, marketing and sales activity to use [their] infringing products.”

 

Ericsson, the wireless carriers’ equipment supplier, then acted to protect its defendant customers against the U by intervening in the Minnesota infringement suit. Ericsson then filed inter partes review (IPR) proceedings in the USPTO to invalidate the U of M patents on which the U was suing the carriers. An IPR is a new type of administrative proceeding that the recent America Invents Act established to provide a swifter and supposedly cheaper way for small companies to resist demands by trolls that they pay patent tribute. Instead of engaging in district court litigation, an aggrieved party can seek an IPR before the USPTO, which then employs its patent expertise to determine whether the patents it issued are invalid, and (if so) consequently relieving the aggrieved party from infringement liability (an invalid patent cannot be infringed).

 

Here is where the complications set in. The 11th Amendment preserves state sovereign immunity against suit—“The Judicial power of the United States shall not be construed to extend to any suit in law or equity, commenced or prosecuted against one of the United States . . . .” Thus, when a patent owner sued a Florida state agency that provided college tuition payment plans, for patent infringement, the Supreme Court held the law subjecting states to infringement liability unconstitutional under the 11th Amendment. Florida Prepaid Postsecondary Ed. Expense Bd. v. College Savings Bank, 527 U.S. 627 (1999). Accordingly, in two January 2017 IPR cases, the USPTO held that the 11th Amendment required it not to allow proceedings before it against Maryland and Florida. Neochord, Inc. v. Univ. of Maryland, Baltimore and Harpoon Medical, Inc., IPR2016-00208 (May 23, 2017), http://www.ptablitigationblog.com/wp-content/uploads/2017/06/IPR2016-00208.pdf; Covidien LP v. University of Florida Research Found. Inc., IPR2016-01274 (Jan. 25, 2017), http://www.finnegan.com/files/upload/LES_Insights_Column/2017/CovidienvUFIPRNos20160126476.pdf. Although waiver was urged, the USPTO said it was inapplicable because the 11th Amendment is jurisdictional—it deprived the tribunal of any jurisdiction to act, so that jurisdiction could be considered at any time. Waiver requires an affirmative act of invoking federal jurisdiction in the relevant tribunal, and that had not occurred.

 

Ericsson argued, in support of its claim that there was jurisdiction to hear its IPR challenges, that the U had waived its 11th Amendment immunity by suing Ericsson’s customers in the Minnesota district court. Ericsson said that the U “has consented to jurisdiction,” when it sued Ericsson’s customers in the district court, because by filing lawsuits against Ericsson’s customers, “it could surely anticipate” that Ericsson would bring an IPR case at the USPTO to invalidate the patents asserted against its customers for using its products. The U has now urged the USPTO to dismiss Ericsson’s IPR cases, insisting that it has not waived its sovereign immunity by suing the phone carriers—not Ericsson, a third party to the U’s patent infringement suits.

 

The U argues that the law is clear that a waiver must be personal, i.e., filing a lawsuit or counterclaims in the same action and in the same forum. Thus, in Regents of Univ. of New Mexico v. Knight, 321 F.3d 1111, 1125 (Fed. Cir. 2003), the Federal Circuit held that it would be unfair to let New Mexico sue in federal court to enforce a right to ownership of patents arising from contracts “and, at the same time, to claim immunity from liability [in the same case] for royalties or other compensation arising from those same contracts and conduct.” The court added, “Moreover, because a state as plaintiff can surely anticipate that a defendant will have to file any compulsory counterclaims [in the same case] or be forever barred from doing so, it is not unreasonable to view the state as having consented to such counterclaims.” Id. at 1126. On the other hand, the Federal Circuit has held that “a state that files a [patent infringement] lawsuit in one district court does not waive its immunity in a related [invalidity declaratory judgment] lawsuit filed by a party in another district court.” Board of Regents of the Univ. of Wis. Sys. v. Phoenix Int’l Software, Inc., 653 F.3d 448, 462 (7th Cir. 2011) (citing Tegic Communications Corp. v. Board of Regents of the Univ. of Texas Sys., 458 F.3d 1335, 1342 (Fed. Cir. 2006)).

 

In the Tegic case, in which UT sued Tegic’s customers for patent infringement in Texas, the Federal Circuit held that UT waived its immunity against a declaratory judgment counterclaim in Texas. But UT did not waive immunity against the separate declaratory judgment action that Tegic wanted to bring in Washington (where Tegic resided). The court said that if Tegic wanted to litigate patent validity, it could intervene in the Texas case and subject itself to infringement liability if the patent was valid and infringed. This is consistent with the Supreme Court’s concept in the College Savings Bank that the 11th Amendment is more about where a state is willing to be sued than whether it can be sued—for example, most states allow suits against them in their own courts of general jurisdiction. (But they don’t want to be sued in another jurisdiction.)

 

Based on this case law, the U argued: “IPR petitions are [not] counterclaims nor adjudicated in the same forum—they are a different action brought in a different forum.” Further, “a state that files an infringement action does not waive its immunity from a different action challenging the patent in a different forum.” The USPTO had said previously that it was not passing on what would happen if the patentee did file a patent infringement suit, as U of M did here. Furthermore, Ericsson did intervene in the Minnesota district court patent infringement suit, as the Tegic court said the equipment seller should if it wanted to challenge validity. But the Minnesota district court has stayed the federal patent action (at Ericsson’s request) to await the result in the IPR case, as district courts usually do in order to let the experts in the USPTO resolve the patent issues for them. (Presumably, the court will vacate its stay if the IPR case is dismissed.)

 

The U quoted the Federal Circuit opinion in Tegic that insisted that Tegic could not show that adjudication of its claim of invalidity was “not available in the Texas action,” and the U then argued, “Similarly, Ericsson cannot show that adjudication of invalidity counterclaims is not available in the Minnesota court,” where the U has (constructively) waived its immunity. There is a serious conflict here between the respective policies of the 11th Amendment that states should not be subjected to forums not of their choice and of the America Invents Act that a cheap, fast, expert determination of patent validity should be available in lieu of litigation in courts. Like the College Savings Bank case, this case may well end up in the Supreme Court. One important issue, not raised or resolved so far, is whether Congress may constitutionally impose, as a condition of the statutory right to acquire the benefit of a patent, and thus make as an integral element of the patent right, that the patent is subject to validity determination in IPR proceedings. Or would the 11th Amendment make that an unconstitutional condition on a benefit, as applied to a state, rather than a legitimate part of the statutory definition of a patent right?


This Time It’s Personal(ized): Pharmaceutical Companies, Dosing Regimen Patents, and Personalized Medicine

Peter Selness, MJLST Staffer

An area of developing healthcare garnering attention in both the medical community and areas of intellectual property law is that of personalized medicine.   Personalized medicine changes the old one-size-fit-all approach of medication dosing to instead tailor medications to each individual patient based upon their genetic make-up.  This practice promises numerous benefits for patient healthcare, but also has some substantial road blocks to overcome before becoming a reality.  Among the issues facing this field of medicine is the controversy surrounding the patentability of personalized medicine methods.  Several recent cases such as Mayo Collaborative Services v. Prometheus Laboratories and Association for Molecular Pathology v. Myriad Genetics, Inc. have raised serious concerns over whether or not personalized medicine methods are based on patentable subject matter.

This concern was taken one step further in the recent article Decline of Dosage Regimen Patents in Light of Emerging Next-Generation DNA Sequencing Technology and Possible Strategic Responses, which discussed the potential impact this may have on the pharmaceutical industry.  Among the concerns addressed was the impact of not being able to obtain patents on dosing regimens for drugs developed by pharmaceutical companies.  While a pharmaceutical company should have no problem patenting a novel medication it has developed, adding additional patent protection to its patent portfolio surrounding that product, such as patents on dosing regimens, has long been a practice utilized to keep competitors at bay.  Considering the massive investment in research and development required to bring a new drug to market (sometimes billions of dollars), pharmaceutical companies are rightly alarmed by any potential loss of patent protection they may experience on their product.  As the article mentioned, this issue will also surely be compounded by the transition to personalized medicine and integrated healthcare, but it may also be a self-solving problem.

Though the article is concerned with the impact personalized medicine may have on pharmaceutical companies if they no longer can obtain patent protection on dosing regimens, researchers developing personalized medicine methods currently face the same issues.  In order for personalized medicine to have an impact on pharmaceutical companies, it must be a fully developed method that has been integrated into everyday healthcare practices.  For that to happen, researchers must have a fundamental understanding of what specific genes give rise to differences in patients’ responses to medication.  This has proven to be a long and expensive process requiring the systematic sequencing of millions of genes from numerous subpopulations of patients; and all of this work is expensive.  Given that the end result of personalized medicine research is a method of administering medication based on an individual’s genetic make-up, patents on personalized medicine fall victim to the same issue facing pharmaceutical companies’ dosing regimen patents.

Lacking the ability to obtain patent protection on personalized medicine methods, the economic feasibility of research in this area becomes more questionable.  To circumvent this dilemma, those within the field of personalized medicine will most certainly be looking for the same solutions as pharmaceutical companies.  Therefore, one of two results will likely occur, both of which may solve the issues of dosing regimen patentability facing the pharmaceutical companies.  One possibility is that the field of personalized medicine will be unable to economically sustain future research without patent protection and fully integrated healthcare will never become a reality; making this issue disappear for pharmaceutical companies.  The other, more likely, possibility is that in order for research in the field of personalized medicine to continue, those researchers will solve the very dilemma that pharmaceutical companies fear will be brought about by the emergence of integrated healthcare.  Either way, pharmaceutical companies’ dosing regimen patents are so closely tied to the fate of personalized medicine patents that the emergence of integrated healthcare most likely cannot occur in a manner that will be detrimental to pharmaceutical companies’ patent portfolio.


Broad Inst. Inc. v. Regents of the Bd. of the Univ. of Cal: PTO to Decide CRISPR Gene Editing Ownership

Jeffrey Simon, MJLST Staffer

The Broad Institute and the University of California will argue claims related to ownership on Patents relating to CRISPR (clustered regular interspaced short palindromic repeats) gene editing technologies. The arguments will be heard on Dec, 6 by the Patent Trial and Appeals Board.

CRISPR technology utilizes prokaryotic DNA segments to confer immunity to foreign genetic elements. CRISPR editing technology has the potential to alter human DNA sequences by removing existing genes or inserting new ones. Moving forward, CRISPR technology has the potential to develop into a form of gene therapy, whereby the human genome can be edited to fortify one’s immune system against infectious diseases or other hereditary issues. CRISPR technology raises ethical concerns, especially relating to the potential use in altering the genes of human embryos.

Although CRISPR technology has been understood for over a decade, the current case revolves around an improvement using cas9 protein that splices DNA at a specific locus. The Broad Institute asserts that patents filed on behalf of the Massachusetts Institute of Technology and Harvard University Researchers (Broad Institute being the eventual assignee of the patents) maintain priority over those owned by University of California. However, the relevant patents have been asserted pre-AIA. Therefore, priority date will be established by date of the invention rather than under the AIA standard of application date. The Patent Trial and Appeals Board (PTAB) initially maintained that the date of invention was properly asserted prior to the patents upon which the challenge was brought. If the decision of the PTAB is upheld, the University of California patents will invalidate the patents held by MIT and Harvard. It’s important to note that both parties are asserting priority date to a previous University of California patent relating to CRISPR technology. The PTAB may determine that both parties failed to prove priority date ahead of the US Patent Application No. 13/842,859, thus invalidating both parties claims.

The Broad Institute is a research institute associated with MIT and Harvard University. It’s unclear how the decision will affect CRISPR technology moving forward. CRISPR technology has attracted lucrative investments from government agencies and private entities alike. Additionally, since the initial patenting of CRISPR, University of California has licensed out the use of CRISPR technology to numerous firms interested in its applications.


A New Year! A New You!: Update Your Look on Regenerative Healing Law

Angela Fralish, MJLST Invited Blogger

Stephen Breyer, Associate Justice for the Supreme Court remarked that in this age of science, we must build legal foundations that are sound in science as well as in law, because a judge is not a scientist and a courtroom is not a scientific laboratory. Further, our decisions should reflect a proper scientific and technical understanding so that the law can respond to the needs of the public.

Human regenerative healing from embryonic stem cell research has sparked many debates on the public’s needs. On one hand, this research has the ability to relieve great suffering and even death, but on the other hand, it is accompanied by the using and destroying of human life. Moral controversy is a dark cloud looming over any courthouse looking to rule on the science of regenerative healing.

Legislative measures have ebbed and flowed with presidencies. Presidents Clinton, Bush and Obama have used executive orders to either expand or reduce federal funding of regenerative healing. President-Elect Trump’s policy is unknown. According to an NPR article issued in November 2016, “his campaign said little about research and development in general, or health research in particular.” This will be an important point in the near future as a Swedish scientist broke taboo in September of this year by altering healthy human embryos. Further, the NIH plans to lift the ban on regeneration in chimeras in early 2017. As it stands, the federal perspective towards future regenerative healing technology remains unclear.

The most recent executive response has been the Cures Act signed on December 13th of last year by President Obama. Sections 3033-3036 support an expedited FDA review of regenerative therapies and demand an update to regulatory law. Practically speaking, this means that clinical trials will be shortened to get the product on the market faster. While some worry this change will compromise ethics, others worry about the United States ability to keep up with a global market. Dr. Brenda Canine quotes, “If concerted long-term investments in research are not made, America will lose an entire generation of young scientists.”

One established principle in regenerative healing is ownership rights under intellectual property law. Challenges have been made on the grounds that researchers are attempting to patent “life,” but courts have allowed ownership rights to certain cell lines. Dr. Nicholas Zachariades wrote in his article titled Stem Cells: Intellectual Property Issues in Regenerative Medicine that “with respect to the stem cells and their use in the field of regenerative medicine, the U.S. Patent and Trademark Office has recognized inventions involving stem cells as patent-eligible subject matter.” He cites to Consumer Watchdog v. Wisconsin Alumni Research Foundation (WARF)  where the plaintiff sued WARF for the patent being too broad, but lost because they lacked standing. WARF maintains a valid patent for “in vitro cell culture.”

Keeping up with science will continue to be a challenge. While it is against norms to destroy healthy embryos, there is a pressing need for the U.S. to compete in a global market. Hopefully, researchers, lawyers and politicians will eventually find a way to merge ethical, legal and federal funding policies related to stem cell research and regenerative healing into a solid legal foundation.


EmDrives: The End of Newtonian Physics?

Peter Selness, MJLST Staffer

The EmDrive has been the center of much controversy over the past decade, and rightfully so.  But what exactly is an EmDrive, and why does it have the scientific community at odds with one another over the underlying science behind it?  The EmDrive is a type of propulsion system that was first designed by Roger Shawyer in 2001.  Essentially, it is a RF resonant cavity thruster that relies on electro magnetic radiation projected into the cavity of a cone to produce thrust.

The EmDrive was met with no small amount of criticism when first proposed because it is what is known as a propellantless propulsion system in that it consumes no fuel when producing thrust.  Not only does it consume no fuel, however, it also appears to only produce force in one direction, thus contradicting Newton’s third law of “for every action there is an equal and opposite reaction.”  Such a proposition has been compared to standing on the deck of a sailboat and pushing on the mast to propel it across a lake, or the old adage of “pulling yourself up by your bootstraps.”  The implications of such a device means that our understanding of physics as it relates to Newton’s third law (which has been relied upon for centuries) is either not entirely understood yet by humanity, or is completely wrong; which is largely why the EmDrive has received such criticism from the scientific community.

And yet, there are multiple confirmed reports of EmDrive testing resulting in this unexplainable thrust that have arisen independently from Roger Shawyer.  Even NASA conducted testing on EmDrives in 2014 and reported measuring a thrust produced by the device.  A similar experiment was then carried out by NASA again in 2015 to correct for some reported errors from the first test, but thrust was surprisingly recorded again despite the corrections.  Also, an EmDrive paper has finally been accepted by peer review by the American Institute of Aeronautics and Astronautics, granting the technology more authority from critics.

Interestingly enough, legal developments have also granted significant legitimacy to the EmDrive.  Roger Shawyer currently has three patents granted on the EmDrive, while two more are still going through the patent process.  Being granted three patents from the UK IP Office means that the physics behind the EmDrive has been thoroughly examined and was found to not violate the laws of physics, as such a violation would inevitably have lead to the patent applications being denied.  Furthermore, Shawyer’s most recent patent, as of October 12th, was filed more than 18 months ago, allowing the patent office to disclose the information contained to the public.  Such a public disclosure should in turn allow for greater scrutiny of Shawyer’s more recent efforts in developing the EmDrive.

The implications of the EmDrive being accepted as a legitimate technology are immense.  First of all, a working propellantless propulsion system would allow for future space craft to be much lighter and cheaper without requiring large amounts of rocket fuel for each take off.  It also would allow for much faster space travel, possibly allowing humans to reach the outer limits of our solar system in a matter of years and Mars within only a few months.  Furthermore, outside its space propulsion systems applications, there’s really no limit to what it may be applied to.

Despite passing several hurdles in recent years, however, the EmDrive is still a long way from leading us to interstellar travel.  The testing conducted by NASA, while showing positive results, also recorded thrust of a force just slightly higher than the magnitude of error for the experiment.  Also, while this positive result allowed it to pass peer review, that does not necessarily mean that the technology is sound and will not later be found to have flaws.  In all likelihood, the chances of a new technology being discovered that, for the first time, violates the laws of physics as we have known them for hundreds of years is a far less likely result than finding some sort of experimental error in the technology.  But maybe, just maybe, this could be the end of Newtonian physics as we know it.


Solving the “Patent Troll” Problem

Travis Waller, MJLST Managing Editor

“Dovre: What’s the distinction between troll and man?

Peer: So far as I know, there is none, by my score.

The big want to roast you, the small ones to scratch you; —

same as with us, if they dare but catch you.”

Henrik Ibsen, Peer Gynt, Act II, ll. 903–06 (John Northam, trans., 2007) (1876).

In recent events, internet “trolling” has become something of a hot issue. This discussion will not address internet trolling (even tangentially), but will instead endeavor to shed light upon a different, often craftier member of troll-kind: the patent troll.

To begin, what is a “patent troll?” The term has taken a somewhat expansive usage since its original appearance in a 1990’s educational video released to corporations. Today, the term can refer to a broad range of practices, but most commonly is understood as the practice of an individual or corporation (sometimes with a large patent portfolio) that abusively uses the threat of enforcement litigation for overly broad, and probably invalid, patents that it has acquired to essentially extort licensing agreements from companies (often quite small) that do not necessarily have the resources to devote to patent litigation, and are likely not even infringing on the “trolls” patented invention to begin with.

Since that was a mouthful, let me provide an example:

Company A (the “troll”) purchases a patent on invention A3;

Company B independently creates invention ABC123, and acquires a patent;

Company A claims that patent A3 reads on patent ABC123, because it claims elements A3 are contained in Company B’s patent ABC123;

Company A sends a letter to Company B demanding that it licenses patent A3, or will face a “prompt” litigation action.

In this example, Company B, fearing that Company A may actually be within it’s legal rights, agrees to pay Company A the fee to license patent A3 for fear of Company A filing expensive patent litigation against Company B, even though a court would almost certainly find that invention ABC123 is nothing like patent A3, and therefore that Company B is not infringing on Company A’s rights (for a few “real world” examples, as well as a dash of technology industry gossip, see this article by Business Insider).

The question arising from situations like this that many courts and lawmakers have hemmed and hawed over is this: who is right? On the one hand, federal patent law strives to protect the rights of the legitimate inventor, and incentivize the very “progress of the useful arts”. On the other hand, how can the law protect companies and individuals like Company B from being bullied by the aggressive assertion of patent rights by companies like Company A?

The answers have manifested themselves mostly through federal and state law making, starting first with the enactment of the Lahey-Smith America Invents Act (the “AIA” for those in the know). This Act modified existing US patent law to allow for a process called “post-grant opposition,” which essentially allows individuals to challenge the validity of a patent after it has been issued by the USPTO, but without having to set foot in a courtroom (theoretically creating a much cheaper option than trial for individuals seeking to invalidate broad patents) (for more info on the process, see here).

The AIA is still relatively new (enacted in 2012), and it is hard to say for certain how this procedure has affected the act of “patent trolling”, however some have made the claim that the AIA has not had the effect of “starving patent trolls” that the lawmakers hoped it would (see here for more discussion on this point).

As such, individual states have taken the fore in this fight against the patent troll, and it is often the case that state consumer protection agencies make up the front lines, by way of various state unfair trade practice laws. However, many state legislatures have taken a much more targeted strategy, and have begun to arm their agencies with the ability to specifically bring actions against individuals and corporations for the “bad faith assertion of patent rights” (as of 2016, Minnesota became one such state).

This action gives state agencies a huge benefit in targeting “troll-like” behavior in the patent industry, but at what cost? Federal patent law preemption issues aside for right now (and yes, they are out there), how exactly will an agency define what “trolling” is? How will state agencies determine that the assertion of the patent right was “in bad faith?” Moreover, how will this effect an otherwise uniform protection that patent holders have across the US?

These questions, and many more, will no doubt need to be addressed by states adopting the “bad faith assertion of patent rights” statutes. For now, since I don’t have an answer off-hand to this incredibly intricate legal and policy question, I will simply eco the words of Henrik Ibsen: “what is the distinction between troll and man?” What is the distinction between patent troll, and legitimate inventor? And finally, are these definitions really something we want to leave in the hands of state agencies, which may or may not be relatively unsophisticated in the intricacies of federal patent law?

My initial impression is one of skepticism, but if the willingness of a great deal of state legislators to adopt such measures can be taken as some indication of a nationwide public demand for a new way to address these issues, maybe this is the start of a conversation that should have happened some time ago.


Halo Electronics v. Pulse Electronics: More Discretion of District Courts in Granting Enhanced Damages

Tianxiang (Max) Zhou, MJLST Staffer

The recent US Supreme Court case, Halo Electronics v. Pulse Electronics, grants district courts more discretion in determining “enhanced damages.” The previous clear standard of the enhanced damages became murkier after this case and left much room for lower courts to decide what constitutes enhanced damages.

Section 284 of the Patent Act provides that, in a case of infringement, courts “may increase the damages up to three times the amount found or assessed.” Enhanced damages are appropriate only when the patentee proves, by clear and convincing evidence, that the infringer “willfully” infringed the patent. Prior to Halo, courts adopted a bifurcated approach to enhanced damages established in In re Seagate: First, the patentee must show the infringer’s recklessness by clear and convincing evidence, that “the infringer acted despite an objectively high likelihood that its actions constituted infringement of a valid patent.” If the objective standard of recklessness is satisfied, then patentee must demonstrate that the risk was either known or so obvious that it should have been known to the accused infringer.

In Halo, the jury in the district court found a high probability that the infringement was willful. However, the district court refused to grant an enhanced damages based on the two-part test, and found as a matter of law, that the patentee did not prove objective recklessness of the infringer. The Federal Circuit Court affirmed the decision.

However, the Supreme Court reversed the Appeal Court’s decision, and rejected the two-part test set forth in In re Seagate. Specifically, the Supreme Court, citing Octane Fitness LLC v. ICON Heath & Fitness, Inc, found that the test is “unduly rigid, and it impermissibly encumbers the statutory grant of discretion to district courts.” Though rejecting the two-part test, the Supreme Court did not give a clear guideline for lower courts to follow. Halo provides that, “[a]s with any exercise of discretion, courts should continue to take into account the particular circumstances of each case in deciding whether to award damages, and in what amount.” According to the Supreme Court, district courts are “‘to be guided by [the] sound legal principles’ developed over nearly two centuries of application and interpretation of the Patent Act.” Besides, the Supreme Court found that the prior two-part test, which requires a finding of objective recklessness, excludes discretionary punishment of “wanton and malicious pirate” who intentionally infringes another’s patent, and a district may grant enhanced damages even in the absence of a finding such objective recklessness.

Overall,  Halo broadened district courts’ discretion in evaluating facts of patent infringement and granting enhanced damages. While the Halo decision will definitely increase the unpredictability of patent infringement lawsuits, it is still unclear whether the broad discretion of district courts will open the gate of flood of enhanced damages. Besides, before we think about the standard of enhanced damages, it is also worthy to consider the policy implications of enhanced damages, and to ask whether and when enhanced damages are appropriate. Anyway, it would be exciting to see a clearer standard of enhanced damages in future cases, or amendments of laws and regulations.


Patent Damages

Tianxiang (Max) Zhou, MJLST Staffer

In Dec. 2015, almost five years after Apple sued Samsung for infringing a smartphone design patent, Samsung agrees to pay Apple $548 million. Apple is now demanding Samsung pay an additional $180 million for the patent dispute. Besides the huge amounts of damages, the case is not over and it continues raising fundamental issues of how to evaluate values of design patent infringements.

In the petition for writ of certiorari challenging the $400 million that it has paid for infringing Apple’s design patent, Samsung writes, “The questions presented are: . . . Where a design patent is applied to only a component of a product, should an award of infringer’s profits be limited to those profits attributable to the component?

The second issue stated in the writ is noteworthy. Under the current rule, the awards in a design patent infringement case to the patent owner are the whole profits from the sale of the infringing products. This rule has created and will create massive jury verdicts in design patent infringement cases, and the Supreme Court has not reviewed the rule. As Samsung writes in the petition, “the Supreme Court has not reviewed a design-patent case in more than 120 years.” With the new development of the industries and various design patents, it is doubted whether the awards of whole profits are reasonable.

Although statistically the Supreme Court will not take the case, the issue of design patent awards raised heated discussions. In 2014, a group of 27 law professors submitted an amicus brief in support of Samsung urging the Federal Circuit to interpret the relevant statutory provision to limit the award of profits in design patent infringement cases. The amicus brief stated: “the Court should require proof of some connection between the patented design and the defendant’s profits, the order the district court to remit the award of profits to the extent it exceeds those profits attributable to the patented designs.” The professors argued the origin and context of the controlling statute Section 289, and that awarding a defendant’s entire profits makes no sense in the modern world, and to prevent disgorgement of profits.

As stated above, the Supreme Court has not reviewed the issue for over one hundred years. With the unsettled dispute between Samsung and Apple continuing, we could look forward to whether the Supreme Court would take the case and redefine Section 289. However, a question posed to the judges is, if the awards to the design patent infringement are not the whole profits of the sale, then what proportion of the profits should be awarded? Judges should figure out a reasonable standard to evaluate the amount attribute to the infringed design.


Supreme Court to Hear Willful Infringement Cases: Will the Justices Clear the Way for Enhanced Damages for Patentees?

Na An, MJLST Staffer

The U.S. Supreme Court granted certiorari to hear two patent cases challenging the current Federal Circuit standard for proving willful infringement on October 19, 2015. The finding of willfulness allows judges to award triple damages, providing more leverage for patentees in licensing and settlement negotiations. The patent litigation world watches with great anticipation as the Court’s Octane Fitness decision rejected a similar rule for awarding attorney’s fees in patent cases last year.

The Federal Circuit established the current willfulness test in its landmark Seagate decision in 2007, which required the patentee to prove that there was an objectively high likelihood that the infringer’s actions constituted infringement and that the likelihood was either known or so obvious that it should have been known to the accused infringer. The Seagate two-prong test overruled decades of precedents that had imposed an affirmative duty on accused infringers to obtain opinion of counsel and posed a substantially heightened burden for a patentee seeking to establish willfulness. Later on, the Federal Circuit recognized the complexity of post-Seagate inquiry and held in Bard Peripheral Vascular that the threshold objective prong of the test is a question of law, reallocating the roles of the judge and jury in determining willfulness of the infringement. Consequently, as opposed to the traditional consideration of willfulness as a question of fact, a district court must now determine whether a reasonable person would have found there to be a high likelihood of infringement (first prong), while the jury determines the patent infringer’s subjective intent (second prong).

Upon a finding of willfulness, the court has discretion to increase the damages up to three times the amount found or assessed, as authorized in 35 U.S.C. § 284. This statutory provision is very similar to § 285, which grants the court power to award reasonable attorney fees in exceptional cases. Before the Supreme Court’s Octane Fitness decision last year, the Federal Circuit restricted its application of § 285 to cases, in which the losing party’s position was “objectively baseless” and brought in “subjective bad faith.” Octane Fitness rejected such a rigid rule and held that judges can decide to award fees when a case “stands out from others.” Seagate’s two-prong test bears a striking resemblance to pre-Octane fee inquiry, sparking much anticipation among practitioners and scholars that the high court would similarly strike down the restrictive willfulness test. The Court found its opportunity in Halo and Stryker.

Halo involves infringement of three US patents, which disclose “surface mount electronic packages containing transformers for mounting on a printed circuit board inside electronic devices.” The Federal Circuit affirmed the district court’s denial of increased damages because the patentee failed to satisfy the objective prong of the Seagate test. Similar issues arose in Stryker. The patents in Stryker were directed to devices that deliver pressurized irrigation for different medical therapies, and the Federal Circuit again denied increased damages due to district court’s failure to undertake an objective assessment of the infringer’s defense. Interestingly, Judge Kathleen O’Malley, concurring in Halo, called for a complete reevaluation of the two-prong test for finding willful infringement, and she reasoned that increased damages and attorney fees should be grouped, given their analogous frameworks and statutory provisions. Therefore, in light of the Octane Fitness decision, the Seagate two-prong test merits reconsideration.

The Federal Circuit voted 8-2 in March not to reconsider the willfulness standard en banc in Halo; nevertheless, the Court granted certiorari without a sharp divide in the lower court. It signals that the Court is unlikely to retain the Seagate standard. But the question remains how much more flexible the new test will be. Will the Court use the same “stands out from others” language in Octane Fitness? Are the justices taking the second prong of the Seagate test away from juries? Or are we going back to the pre-Seagate rule that a mere notice of patent infringement triggers an affirmative duty on the defendant to obtain opinion of counsel? Additionally, the statutory language in § 284 says nothing about willfulness. Will the court give judges even broader discretion to award increased damages in absence of willfulness? If so, is there a danger of more forum shopping? We eagerly await the high court’s decision.


The “Patent Dance” for Now: Rehearing Denied in Amgen v. Sandoz

Jeff Simon, MJLST Staffer

On July 21, 2015, the Federal Circuit’s decision in Amgen v. Sandoz established that a biosimilar applicant does not have to follow the patent dispute resolution procedures set forth by the Biologics Price Competition and Innovation Act. The BPCIA’s “patent dance,” located at 42 U.S.C. § 262(l)(2)(a), sets forth procedures requiring biosimilar applicants to disclose the biosimilar application and information describing the methods and procedures of its production to the sponsor of the reference biologic drug. The Federal Circuit’s fractured decision denied the compulsory nature of the “patent dance,” while still holding that biosimilar applicants are required to provide the biologic drug sponsor 180 days advanced notice of the first commercial marketing of its biosimilar product in accordance § 262(l)(2)(a).

Considering that the decision of the court was split by favoring the biosimilar applicants regarding the issue of the “patent dance” while favoring the biologic sponsor when it came to market disclosure, the decision was far from a satisfying result for either party as neither party came out as the clear victor. As such, both Amgen and Sandoz filed petitions for an en banc rehearing on August 20, 2015. Amgen’s petition for review once again contended that the language of § 262(I)(2)(a) as stated by congress, specifically the use of the word “shall,” indicates that the “patent dance’s” procedures are mandatory. Sandoz contended among other things that the 180-day provision necessarily increases the exclusivity period from 12 years to 12 and a half years and further that the court incorrectly asserted that notice was mandatory and enforceable. Both parties submitted amicus curiae briefs in agreement that, as a matter of first impression, it was appropriate for an en banc rehearing.

However, despite a fractured panel deciding a matter of first impression, Federal Circuit denied a rehearing in decision on October 16, 2015. The decision came as surprise to many of those associated with the biologic drug industry, especially considering the novelty and discord upon the issues. Considering the fact that both parties sought a rehearing, the court may have decided that the issue was undeserving of the court’s continued interest and resources. Both parties may file petitions for certiorari.

In regards to the future implications of the decision, it’s important to note that many of the high revenue pioneer biologic drugs are set to have their US patents expire within the next few years. This expected “patent cliff’ is certain to drive momentum within the biosimilar market. This wave of biosimilar applications is sure to have large implications upon the BPCIA, and particularly whether the “patent dance” is optional. All considered, the issues presented in Amgen may be approaching a level of importance that draws the attention of SCOTUS. It’s possible that a grant of certiorari may be in order to settle the debate on the BPCIA’s “patent dance” and market disclosure requirements, particularly considering the economic ramification of the anticipated biologics’ patent cliff.